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FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

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FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

June 17, 2022: “The U.S. FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. 

  • For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
  • For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. 

Key points:

  • The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
  • The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.
  • Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations. 

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age.  As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.” 

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise. 

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age. 

Information about each vaccine is available in the fact sheets for healthcare providers administering vaccine and the fact sheets for recipients and caregivers.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.” 

Evaluation of the Moderna COVID-19 Vaccine for Individuals 6 Months through 17 Years of Age

Effectiveness

The effectiveness and safety data evaluated and analyzed by the FDA for the Moderna COVID-19 Vaccine to support the EUA for these pediatric populations were generated in two ongoing, randomized, blinded, placebo-controlled clinical trials in the United States and Canada which enrolled infants, children and adolescents.

  • Children 6 months through 5 years of age: Immune responses of a subset of 230 children 6 through 23 months and a subset of 260 children 2 through 5 years of age who received a two-dose primary series of the Moderna COVID-19 Vaccine at 25 micrograms (mcg) of messenger RNA (mRNA) per dose were compared to immune responses among 290 adults 18 through 25 years who received two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In these FDA analyses, the immune response to the vaccine, of both age groups of children, was comparable to the immune response of the adults.  

    An analysis of cases of COVID-19 occurring at least 14 days after the second dose among approximately 5,400 children in this age group without evidence of prior infection with SARS-CoV-2 was conducted during the time period in which the omicron variant was the predominant circulating strain. In this analysis, among participants 6 through 23 months of age, 64% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 50.6% effective in preventing COVID-19. Among participants 2 through 5 years of age, 72% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 36.8% effective in preventing COVID-19.
  • Children 6 years through 11 years of age: Immune responses of a subset of 320 children in this age group who received a two-dose primary series of the Moderna COVID-19 Vaccine at 50 mcg of mRNA per dose were compared to immune responses among 295 adults 18 through 25 years who received two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In the FDA analysis, the immune response of the children to the vaccine was comparable to the immune response of the adults. An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants. 
  • Adolescents 12 through 17 years of age: Immune responses of a subset of 340 adolescents in this age group who received a two-dose primary series of the Moderna COVID-19 Vaccine at 100 mcg of mRNA per dose were compared to immune responses among 296 adults 18 through 25 years who received two equivalent doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In this analysis, the immune response of adolescents was comparable to the immune response of the older participants. 

    An analysis was also conducted of cases of COVID-19 occurring at least 14 days after the second dose among approximately 3,000 adolescents in this age group without evidence of prior infection with SARS-CoV-2, in which approximately 42% of participants had two or more months of blinded follow-up after the second dose. In this analysis, among participants 12 through 17 years of age, the vaccine was 93.3% effective in preventing COVID-19. The data for this analysis were obtained before the omicron variant became the predominant circulating strain.”
  • https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

NICE to evaluate Genedrive® MT-RNR1 Test

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NICE to evaluate Genedrive® MT-RNR1 Test

June 16, 2022: “Genedrive plc, the near patient molecular diagnostics company, announces that the UK’s National Institute for Health and Clinical Excellence (‘NICE’) has started an evaluation of the Genedrive® MT-RNR1 test via their Diagnostics Assessment Programme (‘DAP’).

DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS.


An independent advisory committee considers the evidence provided, makes draft recommendations for public consultation and ultimately makesfinal recommendations for publication in NICE guidance.

The guidance produced is used by NHS commissioners, practitioners, healthcare operational managers and purchasing and procurement organisations.


genedrive’s assay is the world’s first rapid point of care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics.

Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® MTRNR1 test.


David Budd, CEO of genedrive plc, said: “We are grateful to NICE for their engagement and interest in our innovative technology and pleased that the Genedrive® MT-RNR1 test was selected for this programme following successful publication of the NICE Medtech innovation briefing (“MIB290”) in March.

The NICE guidance is an important element required to drive uptake and adoption of the test in the NHS by demonstrating the cost-saving efficiencies.

The application of Genedrive’s technology shows how a rapid, affordable, point-of-care test could impact patients’ treatment and quality of life.”

http://www.genedriveplc.com/press-releases/gdr_-nice(16.06.22).pdf

Jazz and Redx Announce Pan-RAF Inhibitor to Enter Clinical Development

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Jazz and Redx Announce Pan-RAF Inhibitor to Enter Clinical Development

June 15, 2022: “Jazz Pharmaceuticals and Redx announce the U.S. FDA has cleared the Investigational New Drug (IND) application for JZP815, a pan-RAF inhibitor for the treatment of solid tumors and hematologic malignancies that contain mutations in the MAPK pathway, enabling Jazz to proceed with initiating a clinical trial for JZP815.

As a result, a milestone payment of USD $5 million from Jazz payable to Redx has been triggered. 

The milestone payment was triggered under the Agreement in which Jazz acquired Redx’s pan-RAF inhibitor programme, announced on 10 July 2019.

Redx carried out development activities up to the completion of IND-enabling studies.

Today’s milestone is on top of USD $6.5 million already received under the collaboration and Redx remains entitled to development, regulatory and commercial milestone payments as well as incremental tiered royalties in mid-single digit percentages, based on any future net sales.

Preclinical data from this pan-RAF programme was recently presented at the American Association for Cancer Research (AACR) conference in March.

JZP815 is a precision pan-RAF inhibitor with a differentiated mechanism of action, and Jazz expects to assess its utility in treating several types of difficult-to-treat solid tumours where there remains significant unmet patient needs.

Jazz expects to advance JZP815 into a Phase 1 clinical programme and, when initiated, JZP815 will be the fifth compound discovered by Redx to enter the clinic.

Lisa Anson, Chief Executive Officer of Redx, commented: “I am delighted that the IND application for the pan-RAF inhibitor, JZP815, has been accepted.

When Jazz commence the clinical programme this will become the fifth drug candidate discovered by Redx to enter the clinic, further validating our world-class research and development capabilities.

We value the strong relationship we have built with Jazz Pharmaceuticals and look forward to continuing our work together.”

Rob Iannone, M.D., M.S.C.E., Executive Vice President, Global Head of Research and Development of Jazz Pharmaceuticals, commented: “We’re excited to advance JZP815, a precision pan-RAF inhibitor with a differentiated mechanism of action, into a clinical trial programme.

JZP815 may represent a significant advancement in the pan-RAF inhibitor class by not inducing paradoxical pathway activation that can stimulate the growth of certain cancers.

The JZP815 programme exemplifies our continued progress in expanding our early-stage oncology pipeline, and in developing therapies with the potential to address unmet patient need. 

Redx has an exceptional team of research and development scientists and together we have formed an outstanding collaboration, leveraging the strengths of both companies.”

Jazz and Redx also have a separate collaboration agreement to discover and develop drug candidates in the RAS-RAF-MAP kinase (MAPK) pathway, where Redx is again responsible for research and preclinical development activities up to IND application to the FDA.

About Pan-RAF inhibitors
Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.

The Company’s pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs.

The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAFV600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression.

Moreover, B-RAFV600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the compensatory functions of other RAF family members.

Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours.

About JZP815
JZP815 is an investigational, pre-clinical stage pan-RAF kinase inhibitor that was discovered and developed using state-of-the-art screening methodologies and medicinal chemistry.

JZP815 targets specific components of the mitogen-activated protein kinase (MAPK) pathway that, when activated by oncogenic mutations, can be a frequent driver of human cancer.

JZP815 potently inhibits both monomer- and dimer-driven RAF signaling (e.g., RAS-induced), prevents paradoxical pathway activation induced by BRAF selective inhibition, and is active against class 1, class 2, and class 3 BRAF mutants, as well as BRAF fusions and CRAF mutants.

JZP815 is not currently approved for use anywhere in the world. JZP815 is part of Jazz’s growing early-stage R&D pipeline focused on solid tumours and targeted therapy.”

https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-and-redx-announce-pan-raf-inhibitor-jzp815

Bristol Myers Squibb Announces Dividend

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Bristol Myers Squibb Announces Dividend

June 15, 2022: “Bristol Myers Squibb announced that its Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company.

The dividend is payable on August 1, 2022 to stockholders of record at the close of business on July 1, 2022.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2022, to stockholders of record at the close of business on August 9, 2022.

About Bristol Myers Squibb Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.”

https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Announces-Dividend-06f4e09a1/default.aspx

GSK to present bepirovirsen in chronic hepatitis B at International Liver Congress 2022

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GSK to present bepirovirsen in chronic hepatitis B at International Liver Congress 2022

June 15, 2022: “GSK plc will present 12 abstracts at the European Association for the Study of the Liver’s International Liver Congress 2022, taking place on June 22-26 in London.

GSK’s presence will focus on two novel investigational specialty medicines, bepirovirsen, an antisense oligonucleotide for chronic hepatitis B (CHB), and linerixibat, an ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in primary biliary cholangitis (PBC).

Chris Corsico, SVP, Development, GSK said: “New data being shared at this year’s International Liver Congress support our ambition to deliver novel medicines for patients with significant unmet medical need, such as those who suffer from chronic hepatitis B and cholestatic pruritus in primary biliary cholangitis.

We look forward to engaging with the global hepatology community to share the exciting progress we have made for these patients.”

Updates from the bepirovirsen clinical trial programme

New interim analysis data to be shared from the randomised B-Clear phase IIb trial evaluating the efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on and off stable nucleos(t)ide analogue therapy.

Data from this trial will be presented as part of the Late Breaker oral presentation session on June 25 (ILC oral # LB004A, LB004B).

Additional presentations from the bepirovirsen development programme include:

  • Preclinical evidence that bepirovirsen harbours intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8), correlating with clinical efficacy from the study (ILC abstract #3635/ SAT439)
  • Mechanistic pharmacokinetic and pharmacodynamic modelling of the simultaneous effects of bepirovirsen on hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in CHB (ILC abstract #3592/ SAT441).

Data from these trials reflect GSK’s ambition to contribute to the development of a functional cure for people living with CHB and reduce the disease burden for patients.

Updates from the linerixibat clinical trial programme

New analysis to be presented from the GLIMMER phase II trial comparing the health-related quality of life of patients with cholestatic pruritus in PBC to several more common diseases, using EQ-5D, a standardised measure of health utility.

The data from this analysis demonstrate that severe cholestatic pruritus in PBC has a negative impact on health utility that is similar to severe Parkinson’s disease (ILC abstract #1916/ THU470).

Full list of GSK’s presentations at the European Association for the Study of the Liver’s International Liver Congress 2022:

Bepirovirsen

Abstract NamePresenterPresentation details
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection: interim results from the randomised phase 2b B-Clear study Man-Fung Yuen Oral (LB004A, LB004B)
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection not on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study Seng-Gee LimPoster (3595/ SAT452)
Efficacy and safety of bepirovirsen in patients with chronic hepatitis B virus infection on stable nucleos(t)ide analogue therapy: interim results from the randomised phase 2b B-Clear study Man-Fung Yuen Poster (3629/ SAT453)
Evaluation Of Quantitative HBsAg Levels In Chronic Hepatitis B – A Targeted Literature Review Vera Gielen Poster (1850/ SAT405)
Characterisation of baseline complement values in patients with chronic hepatitis B virus infection in the phase IIb B-Clear study Jennifer Cremer  Poster (1994/ THU390)
Characteristics and renal function in patients with chronic hepatitis B virus infection: baseline data from the phase 2b B-Clear study Seng-Gee Lim Poster (1879/ THU389)
Distribution of patients by guideline-defined disease phase and/or grey zones in B-Clear, an international multi-centre clinical trial Seng-Gee Lim  Poster (2127/ THU393)
Bepirovirsen, antisense oligonucleotide (ASO) against hepatitis B virus (HBV), harbors intrinsic immunostimulatory activity via Toll-like receptor 8 (TLR8) preclinically, correlating with clinical efficacy from the Phase 2a study Shihyun You Poster (3635/ SAT439)
Mechanistic Pharmacokinetics/Pharmacodynamics modelling of the simultaneous effects of bepirovirsen on Hepatitis B surface antigen (HBsAg) and alanine transaminase (ALT) changes in Chronic Hepatitis B (CHB) patients: Analysis of Phase 2b study to inform Phase 3 decision-making Ahmed Nader Poster (3592/ SAT441)
Combination treatment of a PAPD5/7 inhibitor with an antisense oligonucleotide bepirovirsen with concurrent dosing shows additive HBsAg decreases in the AAV-HBV mouse modelMartin LeiversPoster (3590/ SAT451)

Linerixibat

Abstract NamePresenterPresentation details
More than just an itch: Impact of cholestatic pruritus in primary biliary cholangitis (PBC) on health-related quality of life (HRQoL) Helen Smith Poster (1916/ THU470)
Linerixibat dose-response analysis of C4 concentrations as a quantitative approach to predict gastrointestinal tolerability Fernando CarreñoPoster (2056/ THU472)
Investigation of linerixibat 40mg BID for cholestatic pruritus of primary biliary cholangitis (PBC); further data from the Phase 2b GLIMMER study to support the Phase 3 GLISTEN study James Fettiplace Poster (3606/ THU485)

About chronic hepatitis B

Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus (HBV), it can cause both acute and chronic liver disease.

Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body’s immune system is unable to fight off the virus and it persists in the blood and liver.

It is estimated that there are 296 million people globally living with CHB.1 Even when treated, CHB can progress to liver complications including cirrhosis and liver cancer, which results in nearly 900,000 deaths per year.

Viral suppression is the current goal for treatment of CHB. However, viral replicative activity may return upon cessation of treatment requiring lifelong therapy to prevent viral rebound.

The concept of functional cure of CHB aims to eliminate the virus from circulating in the blood and prevent any disease activity in the liver.

As only a limited number of patients currently treated for CHB achieve HBsAg loss, considered the hallmark for achieving functional cure, development of therapeutic approaches to reach functional cure are needed.”

https://www.gsk.com/en-gb/media/press-releases/gsk-to-present-new-data-from-the-b-clear-phase-iib-trial-for-bepirovirsen-in-chronic-hepatitis-b-at-the-international-liver-congress-2022/

FDA Approves First Systemic Treatment for Alopecia Areata

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FDA Approves First Systemic Treatment for Alopecia Areata

June 13, 2022: “The U.S. FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.

Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research.

“Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps.

Olumiant is a Janus kinase (JAK) inhibitor which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.

The efficacy and safety of Olumiant in alopecia areata was studied in two randomized, double-blind, placebo-controlled trial (Trial AA-1 and Trial AA-2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than six months.

Patients in these trials received either a placebo, 2 milligrams of Olumiant, or 4 milligrams of Olumiant every day.

The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo.

In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo.  

The most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase,  urinary tract infection,  liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster) and weight increase.  

Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Olumiant comes with warnings and precautions including recommending close monitoring for the development of signs and symptoms of infection during and after treatment; evaluating patients for active tuberculosis infection and testing for latent tuberculosis prior to treatment with Olumiant; and the potential for viral reactivation.

In addition, other warnings and precautions include hypersensitivity (allergic reactions), gastrointestinal perforations (tears in stomach or intestine), and laboratory abnormalities including low white and red blood cell counts, liver enzyme elevations and lipid elevations.

Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

Olumiant received priority review and breakthrough therapy designations for this indication.

Olumiant was originally approved in 2018.

It is approved as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis.

Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults.  

The FDA granted the approval of Olumiant to Eli Lilly and Company.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata
 

Sanofi-GSK next-generation COVID-19 booster delivers strong immune response

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Sanofi-GSK next-generation COVID-19 booster delivers strong immune response

June 13, 2022: “Sanofi reports data from two trials, VAT02 Cohort 2 and COVIBOOST VAT013, conducted with its new next-generation COVID-19 booster vaccine candidate modelled on the Beta variant antigen and including GSK’s pandemic adjuvant.

In the Phase 3 VAT02 Cohort 2 study, the Sanofi-GSK next-generation vaccine candidate induced (at day 15 post-immunization) a significant boost in antibody titers above baseline against multiple variants of concern (15-fold increase against D614 parent virus, 30-fold increase against Beta strain) in adults previously primed with mRNA COVID-19 vaccines.

In particular against Omicron, preliminary data show a 40-fold increase against BA.1.

The Sanofi-GSK next-generation booster candidate generated double the number of neutralizing antibodies against Omicron BA.1 and BA.2 compared to the D614-based (original parent virus) booster.

In parallel, the independent COVIBOOST (VAT013) study conducted by the Assistance Publique – Hôpitaux de Paris (AP-HP) demonstrated that, following primary vaccination with two doses of Pfizer-BioNTech’s Comirnaty vaccine, the Sanofi-GSK next-generation booster candidate generated a higher immune response (as measured by neutralizing antibody titers) than Pfizer-BioNTech’s booster or the Sanofi-GSK first-generation booster, both of which target the original D614 parent strain.

The proportion of participants with at least a 10-fold increase in neutralizing antibody titers for the original D614 SARS-CoV-2 strain between day 0 and day 15 was:

  • 76.1% (95% CI 64.5–85.4) for the Sanofi-GSK next-generation booster, vs
  • 63.2% (95% CI 51.3–73.9) for the Pfizer BioNTech D614 booster, and
  • 55.3% (95% CI 43.4–66.7) for the Sanofi-GSK D614 (first-generation parent booster candidate).

In this study, which included 247 subjects, all the three vaccines also elicited neutralizing antibodies against the Omicron BA.1 variant, with highest responses generated by the Sanofi-GSK next-generation candidate.

Results of COVIBOOST study are available on a pre-print server, pending publication in a peer-reviewed journal.Across both studies, the Sanofi-GSK next-generation vaccine candidate was well-tolerated, with a favorable safety profile. In the VAT02 cohort 2 study, low numbers (less than 4%) of Grade 3 reactions were reported, all transient and non-severe.

Thomas Triomphe
Executive Vice President, Sanofi Vaccines
“COVID-19 keeps evolving and the combination of emergence of variants and waning immunity is likely to lead to the need for additional booster shots, at least in some populations. 

The Beta variant expresses similar mutations across multiple variants of concern, including Omicron, making it a strong vaccine candidate to confer broad protection against multiple strains of COVID-19. 

Seeing the cross-neutralization data from the independent AP-HP study, we believe this next-generation booster could have an important role to play for public health vaccination campaigns.

We look forward to submitting these data to global regulatory authorities.”

Sanofi and GSK have developed their next-generation booster candidate in parallel to ongoing regulatory reviews of their first-generation vaccine candidate.

The totality of data supporting this next-generation booster vaccine will be submitted to regulatory authorities in the upcoming weeks, with the aim of making it available later this year.

About VAT02
The VAT02 booster study is an extension of the company’s phase 3 safety and immunogenicity study.

In Cohort 1 of this study, participants previously vaccinated with the primary series of an authorized COVID-19 vaccine received a booster dose of the Sanofi-GSK adjuvanted recombinant vaccine candidate, using SARS-CoV-2 (D614) antigen.

These data confirmed the vaccine candidate’s universal potential to boost neutralizing antibodies 18- to 30-fold across all vaccine platforms (mRNA, protein, adenovirus). Cohort 2 included 1,500 participants.

VAT02 results will be published in a peer-reviewed journal at a later date.

These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S.

Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002 and by the National Institute of Allergy and Infectious Diseases (NIAID).

The NIAID provides grant funding to the HIV Vaccine Trials Network (HVTN) Leadership and Operations Center (UM1 AI 68614HVTN), the Statistics and Data Management Center (UM1 AI 68635), the HVTN Laboratory Center (UM1 AI 68618), the HIV Prevention Trials Network Leadership and Operations Center (UM1 AI 68619), the AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI 68636), and the Infectious Diseases Clinical Research Consortium (UM1 AI 148684, UM1 AI 148450, UM1 AI 148372 , UM1 AI 148574).

About COVIBOOST (VAT013) study
COVIBOOST is an independent study conducted by the Assistance Publique – Hôpitaux de Paris (AP-HP).

It is a randomized, single-blinded, multicenter trial across 11 centers in France, which studies the immune response of the Sanofi-GSK first- and next-generation booster vaccine candidates (adjuvanted, recombinant protein) and that of a 3rd dose of the Pfizer-BioNTech vaccine Comirnaty, following two doses of Comirnaty received as primary vaccination.

The study was funded by the French Ministry of Solidarity and Health and Sanofi.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-06-13-05-30-00-2460833

Novartis five-year Kymriah® data show durable remission and long-term survival

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Novartis five-year Kymriah® data show durable remission and long-term survival

June 12, 2022: “Novartis announced long-term results from the ELIANA pivotal clinical trial of Kymriah® (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL), with a maximum survival follow-up of 5.9 years.

For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission within three months of infusion (n=65) was 43.8 months.

These findings demonstrate the curative potential of Kymriah, the only CAR-T cell therapy available for these patients who previously had limited treatment options.

These data were presented as an oral presentation during the 2022 European Hematology Association (EHA) Hybrid Congress (Abstract #S112)1.

“These data mark a moment of profound hope for children, young adults and their families with relapsed or refractory B-cell ALL, as relapse after five years is rare,” said Stephan Grupp, MD, PhD, Section Chief of the Cellular Therapy and Transplant Section, and Inaugural Director of the Susan S. and Stephen P. Kelly Center for Cancer Immunotherapy at Children’s Hospital of Philadelphia (CHOP).

“Since the approval of Kymriah nearly five years ago, we have been able to offer a truly game-changing option to patients who previously faced a five-year survival rate of less than 10 percent.”

This long-term follow up of ELIANA demonstrated the potential for Kymriah to transform cancer treatment in pediatric and young adult patients with r/r B-cell ALL, significantly improving outcomes with durable responses and a consistent safety profile in this patient population:

  • Eighty-two percent of patients experienced remission (either complete remission [CR] or CR with incomplete hematologic recovery within three months after infusion) (95% CI, 72-90)
  • For patients in remission, the five-year relapse-free survival (RFS) rate was 44% (95% CI, 31-56) and the median RFS was 43 months
  • No new or unexpected adverse events were reported during long-term follow-up

“At Novartis, we strive for cures. With nearly six-year follow-up data in these pediatric and young adults treated for B-cell ALL, we have our strongest evidence yet that one-time treatment with Kymriah has curative potential,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development.

“These results strengthen our confidence in CAR-T cell therapies as a truly transformative and paradigm-shifting advance in cancer care, as well as our commitment to continue developing this technology with next-generation platforms.”

Additional updates on the Novartis CAR-T program presented at the 2022 EHA Congress include new data from more patients and longer follow-up from the first-in-human dose-escalation trials with YTB323 in adults with r/r diffuse large B-cell lymphoma and PHE885 in adults with r/r multiple myeloma, the first Novartis CAR-T cell therapies developed using the Novartis T-Charge™ platform.

Visit https://www.hcp.novartis.com/virtual-congress/eha-2022/ to learn more about these data and our ongoing commitment to reimagining cancer care with CAR-T cell therapies.

About Kymriah®
Kymriah is the first-ever FDA-approved CAR-T cell therapy.

It is a one-time treatment designed to empower patients’ immune systems to fight their cancer.

Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), r/r adult diffuse large B-cell lymphoma (DLBCL) and r/r adult follicular lymphoma.”

https://www.novartis.com/news/media-releases/novartis-five-year-kymriah-data-show-durable-remission-and-long-term-survival-maintained-children-and-young-adults-advanced-b-cell-all

AZ demonstrates pipeline and portfolio strength across malignant and rare haematological diseases at EHA 2022

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AZ demonstrates pipeline and portfolio strength across malignant and rare haematological diseases at EHA 2022

June 09, 2022: “AstraZeneca will showcase data demonstrating the Company’s commitment to redefine care in haematology at the European Hematology Association (EHA) Annual Meeting, 9 to 12 June 2022.

A total of five approved and potential new medicines from AstraZeneca will be featured across 16 abstracts, including one oral presentation.

These include long-term follow-up data for Calquence (acalabrutinib) in adults with previously untreated and relapsed or refractory chronic lymphocytic leukaemia (CLL).

Additionally, Alexion, AstraZeneca’s Rare Disease group, will present an analysis of long-term survival data from the clinical trial programme evaluating Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).

One-year safety and efficacy data from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris will also be presented.

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: “At this year’s European Hematology Association Annual Meeting, we are demonstrating our strength across a broad spectrum of haematological malignancies, and specifically in chronic lymphocytic leukaemia, to help improve outcomes for these patients.

The data from our portfolio and pipeline represent the outcome of years of dedication and passion focused on delivering improved treatment options that can have a long-term impact for patients with chronic, hard-to-treat and rare blood conditions.”

Christophe Hotermans, MD, PhD, Senior Vice President, Global Medical Affairs, Alexion, said: “The collective clinical and real-world data being presented at the European Hematology Association Annual Meeting will strengthen the body of scientific evidence supporting the effective and well-tolerated use of targeted C5 complement inhibition, which is the standard of care in paroxysmal nocturnal haemoglobinuria.

The data reinforce targeting of the terminal complement system through C5 inhibition to reduce intravascular haemolysis and thrombosis in this devastating disease.”

Redefining expectations for patients with CLL

  • Updated data from the ELEVATE-TN Phase III trial at approximately five years of median follow-up will highlight longer-term safety, progression-free survival (PFS) efficacy results and overall survival rates for Calquence in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with previously untreated CLL.
  • Updated data from the ASCEND Phase III trial at approximately four years of median follow-up will highlight longer-term safety and PFS efficacy results of Calquence alone compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in adults with relapsed or refractory CLL.
  • A pooled analysis of data among previously untreated and relapsed or refractory CLL patients with higher-risk genomic features taking Calquence will explore the efficacy of Calquence-based regimens for these sub-groups of patients, regardless of line of therapy.
  • A crossover analysis from the ELEVATE-TN trial will test the hypothesis that treatment crossover upon disease progression from the obinutuzumab plus chlorambucil arm to the Calquence arm bolstered overall survival for the obinutuzumab plus chlorambucil arm at 47 months of follow-up.

Improving understanding of hard-to-treat blood cancers

  • A post-hoc analysis of the ACE-LY-004 Phase II trial will highlight the clinical benefit seen with patients taking Calquence who had one prior therapy and with highly proliferative variants of relapsed or refractory mantle cell lymphoma (MCL).
  • Final results at five-year median follow-up from the WM-001 Phase II trial will highlight response rates and tolerability seen with Calquence in patients with previously untreated or relapsed or refractory Waldenström macroglobulinemia (WM).
  • Early results from a Phase II trial will show the efficacy and tolerability of Calquence in patients with relapsed or refractory marginal zone lymphoma (MZL).

Advancing treatment and care for patients with PNH

  • Pooled, long-term, survival data for more than four years from the Ultomiris PNH clinical trial programme will highlight long-term use of Ultomiris in the treatment of adults with PNH.

    Ultomiris has the largest clinical trial programme in PNH, with the longest follow-up, and demonstrates the benefits of immediate, complete and sustained terminal complement inhibition in this rare disease.
  • Data through one year on the efficacy, safety and treatment administration satisfaction will be presented from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris with an on-body delivery system in adults with PNH who had received prior intravenous treatment with Soliris (eculizumab).

Key AstraZeneca presentations during EHA 2022

Lead authorAbstract titlePresentation details
Calquence (acalabrutinib)
Sharman, JPAcalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naive Chronic Lymphocytic Leukemia: 5-Year Follow-up of ELEVATE-TN Abstract # P666Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Ghia, PAcalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up Abstract # P668Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Davids, MSLong-term Efficacy of Acalabrutinib-Based Regimens in Patients With Chronic Lymphocytic Leukemia and Higher-risk Genomic Features: Pooled Analysis of Clinical Trial Data Abstract # P667Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Gaitonde, PAdjusting Survival Data for Treatment Crossover in the ELEVATE-TN Trial by Using a Historical Cohort of Patients Treated with Chemoimmunotherapy in Front-Line Chronic Lymphocytic Leukemia Abstract # PB1877e-PublicationOnline Only12 May 2022
Le Gouill, SPost Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib Abstract # P1131Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Owen, RAcalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study Abstract # P1130Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Strati, PAcalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial Abstract # P1129Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Ultomiris (ravulizumab)
Kulasekararaj, ALong-Term Complement Inhibition and Survival Outcomes in Patients with Paroxysmal Nocturnal Hemoglobinuria: An Interim Analysis of the Ravulizumab Clinical TrialsAbstract # P812Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Yenerel, MEfficacy, Treatment Administration Satisfaction and Safety of Subcutaneous Ravulizumab Through 1 Year in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous EculizumabAbstract # P813Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Soliris (eculizumab)
Nishimura, JReal-World Outcomes of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinurea: A Systematic Literature Review and Evidence SynthesisAbstract # PB1934e-PublicationOnline Only12 May 2022
Rovó, AReal-World Evidence of Safety and Effectiveness of Eculizumab and Switch to Ravulizumab in a Swiss Patient Population With Paroxysmal Nocturnal HemoglobinuriaAbstract # P834Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
ALXN1820
Kim, SProperdin-Blocking Antibodies Attenuate Complement Alternative Pathway Activation Triggered by Cell-Free Heme in Sickle Cell Disease ModelsAbstract # S267Oral PresentationSession – Sickle Cell Disease: Novel Biomarkers and Therapies12 June 202211:30 – 12:45 CEST

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-demonstrates-pipeline-and-portfolio-strength-across-malignant-and-rare-haematological-diseases-at-eha-2022.html

FDA accepts Dupixent® for priority review in adults with prurigo nodularis

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FDA accepts Dupixent® for priority review in adults with prurigo nodularis

May 31, 2022. The U.S.FDA has accepted for priority review the sBLA for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions.

The target action date for the FDA decision is September 30, 2022.

The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis (PRIME2 and PRIME).

Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions.

The safety results from these trials were generally consistent with the known safety profile of Dupixent in atopic dermatitis. The adverse event more commonly observed with Dupixent was conjunctivitis.

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Additional regulatory filings outside of the US are also planned in 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

About Prurigo Nodularis
People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.

Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin.

The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions.

High-potency topical steroids are commonly prescribed but are associated with safety risks if used long term.
There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-05-31-07-00-00-2452848

Sandoz launched initiative to support improved healthcare access, equity and sustainability

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Sandoz launched initiative to support improved healthcare access, equity and sustainability

May 31, 2022: “Sandoz, a global leader in generic and biosimilar medicines announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide.

Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars.

The initiative is supported by a multidisciplinary Steering Committee of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders from around the world, with a mission to increase global adoption of biosimilar medicines by at least 30% in 30+ countries by 2030.

A biosimilar is a successor to a biological medicine (also known as “reference medicine”) for which the patent has expired and exclusivity has been lost.

Biosimilars match their respective reference medicine in terms of quality, safety and efficacy. Hence, the biosimilar can be expected to behave in the same way as the reference medicine in all indications and patient populations that the reference medicines are approved in.

Biosimilars are used in the treatment and prevention of many disabling and life-threatening diseases such as cancer, psoriasis, arthritis, and diabetes.

“As a result of their affordability, biosimilars have opened up a new realm of possibility for patients by enabling biological medicines to become more widely available to those in need of these advanced, life-changing treatments,” said Zorana Maravic, CEO, Digestive Cancers Europe. 

“However, until we address existing biosimilar access inequities, far too many patients will continue to miss out on treatment with the best possible medicines.”

Act4Biosimilars.com outlines the 12 goals that have been identified under the 4As by the Steering Committee to achieve the mission.

These include ensuring equitable pricing, involving patients in treatment decisions and streamlining biosimilar development.

As an immediate next step, the Steering Committee is developing an Action Plan to provide the strategies, tools and activities needed to equip and empower stakeholders to realize these 12 goals, across the 30 countries and beyond.

The Action Plan will be supported by Country Indicator Maps to track and measure the change that is being driven by groups, associations and organizations worldwide.

“While countries such as Norway are leading the way in biosimilar adoption and have successfully realized significant healthcare savings through increasing availability of biosimilars, there are other countries still progressing and aspiring to reach their full potential,” said Professor emeritus Tore K Kvien, previous Head of Department of Rheumatology, Diakonhjemmet Hospital for 25 years.

“Misinformation on the safety, efficacy and science of biosimilars continues to cause confusion and impede uptake. With the Act4Biosimilars Action Plan, we will prioritize the steps needed to help better educate, inform and create action across all countries and regions.”

The Steering Committee will co-create the Action Plan with a group of biosimilar experts and key stakeholders, including patient organizations, healthcare professionals, trade associations, think tanks, government bodies and professional societies.

Act4Biosimilars is supported by founding sponsor Sandoz, a pioneer and global leader in biosimilars, who developed and brought the first biosimilar medicine to patients 16 years ago.

“Healthcare systems are facing more pressure than ever before, which can be attributed to the costs associated with a growing, aging population, more people being diagnosed with chronic diseases and, most recently, the pandemic,” said Richard Saynor, Chief Executive Officer, Sandoz.

“Biosimilars are part of the solution to support a more sustainable healthcare system for all and we are proud to be the founding sponsor of Act4Biosimilars, which will drive action to bring these more affordable treatment options to patients who need them.”

https://www.novartis.com/news/media-releases/sandoz-announces-new-global-act4biosimilars-initiative-improve-patient-access-and-increase-adoption-least-30-30-countries-2030

FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

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FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

May 27, 2022: “The U.S. Fda is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months.

“We continue to work around the clock with our government partners and industry to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D.

“Steps like the one the agency is taking today means more infant formula will be available to parents and caregivers in the weeks and months ahead. We will not rest until our shelves are replete with safe and nutritious infant formula.”

Under the agency’s recent increased flexibilities, Bubs Australia plans to provide at least 1.25 million cans of several varieties of its infant formula such as stage 1 and 2 cans of Bubs Organic Grass Fed, Bubs Supreme A2 Beta-Casein Protein and Bubs Easy-digest Goat Milk, that will make at least 27.5 million full-size, 8-ounce bottles.

Some of this product is currently in stock for transport and additional product is being produced in the coming weeks and months. The U.S. Department of Health and Human Services is evaluating options for getting the products to the U.S. as quickly as possible.

The company has information about the products and where to find product once in the U.S. on the Aussie Bubs websiteExternal Link Disclaimer.

The FDA notified Bubs Australia that the agency is exercising enforcement discretion for the importation of certain infant formula products following the review of information provided pertaining to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about facility production and inspection history. 

On Tuesday and Thursday, the FDA also announced steps that will lead to tens of millions of additional bottles of infant formula, including specialty infant formula that is in short supply for infants with certain allergies or critical health conditions.

The agency is leveraging a number of flexibilities to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition.

The FDA remains in further discussions with manufacturers and suppliers regarding additional supply to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it.

The FDA issued guidance on May 24 that outlined a process by which the agency would not object to the importation of certain infant formula products intended for a foreign market or distribution in the U.S. of products manufactured here for export to foreign countries.

This guidance also may provide flexibilities to those who manufacture infant formula products domestically and may be able to increase further the quantity of domestically produced product for the U.S. market.

The agency has posted a webpage that will be updated with information about additional products headed to the U.S.

The agency’s around-the-clock work as part of the all-of-government efforts has already begun to improve supply and availability.

The agency expects that the measures and steps it is taking, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, will mean more and more supply is on the way or on store shelves moving forward. 

The FDA continues to advise against making infant formulas at home or diluting formula.

Caregivers are encouraged to work with their child’s health care provider for recommendations on changing feeding practices, if needed.

HHS has also released a fact sheet with information to help families find infant formula.

The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove violative and harmful products offered for sale on their sites.

Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry.

The FDA also monitors and follows up on various external signals such as consumer complaints about potential counterfeit and fraudulent products.

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.”

https://www.fda.gov/news-events/press-announcements/fda-efforts-result-millions-additional-bottles-infant-formula-further-increase-us-supply

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